History of Changes for Study: NCT05146336

CytOSorb TreatMent Of Critically Ill PatientS Registry (COSMOS)

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Study Record Versions

Version	Submitted Date	Changes
1	November 23, 2021	None (earliest Version on record)
2	May 5, 2022	Study Status and Contacts/Locations
3	June 13, 2022	Contacts/Locations and Study Status
4	June 23, 2022	Contacts/Locations and Study Status
5	July 6, 2022	Study Status
6	July 20, 2022	Recruitment Status, Study Status, Contacts/Locations and Oversight
7	October 13, 2022	Contacts/Locations and Study Status
8	November 17, 2022	Contacts/Locations, Eligibility and Study Status
9	December 1, 2022	Contacts/Locations and Study Status
10	March 22, 2023	Contacts/Locations and Study Status
11	April 6, 2023	Contacts/Locations and Study Status
12	May 11, 2023	Contacts/Locations and Study Status
13	July 7, 2023	Contacts/Locations and Study Status
14	August 24, 2023	Contacts/Locations and Study Status
15	September 19, 2023	Contacts/Locations and Study Status
16	October 19, 2023	Study Status and Contacts/Locations
17	October 23, 2023	Contacts/Locations and Study Status
18	October 25, 2023	Contacts/Locations and Study Status
19	October 30, 2023	Contacts/Locations and Study Status
20	February 19, 2024	Study Status, Contacts/Locations, Eligibility, Study Design and Conditions
21	April 4, 2024	Study Status and Contacts/Locations
22	April 10, 2024	Contacts/Locations and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	O06
Brief Title:	CytOSorb TreatMent Of Critically Ill PatientS Registry (COSMOS)
Official Title:	CytOSorb TreatMent Of Critically Ill PatientS Registry: International Registry on the Use of CytoSorb in the Critical Care Setting
Secondary IDs:

Study Status


Record Verification:	September 2023
Overall Status:	Recruiting
Study Start:	June 22, 2022
Primary Completion:	March 2031 [Anticipated]
Study Completion:	June 2031 [Anticipated]

First Submitted:	November 23, 2021
First Submitted that Met QC Criteria:	November 23, 2021
First Posted:	December 6, 2021 [Actual]

Last Update Submitted that Met QC Criteria:	September 19, 2023
Last Update Posted:	September 21, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	CytoSorbents, Inc
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description


Brief Summary:	Registry intended to provide a data repository and reporting infrastructure for the surveillance of CytoSorb device use in real-world critical care settings, and to serve as an objective, comprehensive, and scientifically-based resource to measure and improve the quality of patient care
Detailed Description:

Conditions


Conditions:	Critical Illness Septic Shock Vasogenic Shock Acute Respiratory Distress Syndrome Severe Acute Respiratory Syndrome Liver Failure Trauma Rhabdomyolysis Corona Virus Infection Vasoplegic Syndrome Cardiogenic Shock Pancreatitis
Keywords:

Study Design


Study Type:	Observational [Patient Registry]
Observational Study Model:	Cohort
Time Perspective:	Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment:	3000 [Anticipated]
Number of Groups/Cohorts	0
Target Follow-Up Duration:	1 Year

Groups and Interventions


Intervention Details:
	Device: CytoSorb Sorbent hemoperfusion system

Outcome Measures


Primary Outcome Measures:
1.	ICU mortality [ Time Frame: Through ICU discharge or date of death, whichever comes first [on average 7 days] ]
2.	In-hospital mortality [ Time Frame: Through hospital discharge or date of death, whichever comes first [on average 14 days] ]

Eligibility


Study Population:	Critically ill patients receiving CytoSorb therapy
Sampling Method:	Non-Probability Sample
Minimum Age:
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: CytoSorb® 300 mL device utilization Informed consent for prospective registry participation Exclusion Criteria: Use of the CytoSorb® 300 mL device for antithrombotic removal only Intraoperative use of CytoSorb® 300 mL device during cardiac surgery only

Contacts/Locations


Central Contact Person:	Marie-Christin Pawlik, PhD Telephone: +49 30 654 99 145 Email: cosmos@cytosorbents.com
Central Contact Backup:	Robert Wilke Telephone: +49 30 654 99 145 Email: cosmos@cytosorbents.com
Study Officials:	Ricard Ferrer Roca, MD Principal Investigator Hospital Vall d'Hebron
Locations:	Germany
	Herz- und Diabeteszentrum Nordrhein-Westfalen [Recruiting] Bad Oeynhausen, Germany, 32545 Contact:Principal Investigator: Thomas Kirschning, MD
	Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum [Recruiting] Bochum, Germany, 44789 Contact:Principal Investigator: Andreas Baumann, MD
	St. Josef-Hospital - Katholisches Klinikum Bochum [Recruiting] Bochum, Germany, 44791 Contact:Principal Investigator: Martin Bellgardt, MD
	Universitätsklinikum Essen, Klinik für Nephrologie [Recruiting] Essen, Germany, 45147 Contact:Principal Investigator: Andreas Kribben, MD, Prof
	Universitätsklinikum Essen, Klinik für Thorax- und Kardiovaskuläre Chirurgie [Recruiting] Essen, Germany, 45147 Contact:Principal Investigator: Matthias Thielmann, MD, Prof
	Universitätsklinikum Essen, Medizinische Intensivtherapie I [Recruiting] Essen, Germany, 45147 Contact:Principal Investigator: Bartosz Tyczynski, MD
	Universitätsmedizin Göttingen, Herzzentrum Göttingen [Recruiting] Göttingen, Germany, 37075 Contact:Principal Investigator: Aschraf El-Essawi, MD, PD
	Klinikum Herford [Not yet recruiting] Herford, Germany, 32049 Contact:Principal Investigator: Dietrich Henzler, MD, Prof
	Universitätsklinikum Marburg [Recruiting] Marburg, Germany, 35043 Contact:Principal Investigator: Julian Kreutz, MD
	Kliniken Maria Hilf [Recruiting] Mönchengladbach, Germany, 41063 Contact:Principal Investigator: Athina Gavriil
	Deutsches Herzzentrum München [Recruiting] München, Germany, 80636 Contact:Principal Investigator: Thomas Günther, MD, PD
	Klinikum Oldenburg [Recruiting] Oldenburg, Germany, 26133 Contact:Principal Investigator: Ulf Günther, MD, PD
	Helios Dr. Horst Schmidt Kliniken Wiesbaden [Recruiting] Wiesbaden, Germany, 65199 Contact:Principal Investigator: Moritz Unglaube, MD
	Italy
	Ospedale Pediatrico Bambino Gesù [Not yet recruiting] Roma, Italy, 00165 Contact:Principal Investigator: Gabriella Bottari, MD
	Ospedale Casa Sollievo della Sofferenza [Not yet recruiting] San Giovanni Rotondo, Italy, 71013 Contact:Principal Investigator: Filippo Aucella, MD
	Spain
	Hospital Universitari Vall d'Hebron [Recruiting] Barcelona, Spain, 08035 Contact:Principal Investigator: Ricard Ferrer Roca, MD

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: